EXERGEN CORPORATION

Address:400 PLEASANT STREET,Watertown,MA,02472,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Thermometer, Electronic, Clinical (FLL) (10)

Premarket Exempt

Clear

Exergen Temporal Scanner - 10834098000133 Catalog Number : 124282, 124287, 124291, 124295, 124278, 124282-R, 124282-RC, 124289, 124293

Device Description : TAT5000 Quick Release Oral Calibration

Device Class : 2

Duns Number: 061266060

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Exergen Temporal Scanner - 10834098000140 Catalog Number : 124280

Device Description : TAT5000 Dual Security 5 Arterial Calibratiom

Device Class : 2

Duns Number: 061266060

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Exergen Temporal Scanner - 10834098000157 Catalog Number : 124281

Device Description : TAT5000 Dual Security 5 Oral Calibration

Device Class : 2

Duns Number: 061266060

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Exergen Temporal Scanner - 10834098000164 Catalog Number : 124392

Device Description : TAT5000 Dual Security 20 Arterial Calibration

Device Class : 2

Duns Number: 061266060

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Exergen Temporal Scanner - 10834098000171 Catalog Number : 124393

Device Description : TAT5000 Dual Security 20 Oral Calibration

Device Class : 2

Duns Number: 061266060

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Exergen Temporal Scanner - 10834098000188 Catalog Number : 124003, 124003-R

Device Description : TAT5000S-TTL Arterial Calibration - Fahrenheit

Device Class : 2

Duns Number: 061266060

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Exergen Temporal Scanner - 10834098000195 Catalog Number : 124006, 124006-R

Device Description : TAT5000S-TTL Oral Calibration - Fahrenheit

Device Class : 2

Duns Number: 061266060

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Exergen Temporal Scanner - 10834098000201 Catalog Number : 124004, 124004-R

Device Description : TAT5000S-TTL Arterial Calibration - Celcius

Device Class : 2

Duns Number: 061266060

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Exergen Temporal Scanner - 10834098000218 Catalog Number : 124005, 124205-R

Device Description : TAT5000S-TTL Oral Calibration - Celcius

Device Class : 2

Duns Number: 061266060

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Exergen Temporal Scanner - 10834098000225 Catalog Number : 124260, 124260-R

Device Description : TAT5000S-USB Arterial Calibration - Fahrenheit

Device Class : 2

Duns Number: 061266060

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

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